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FDA 510(k)

Powder Free Nitrile Examination Gloves, Blue Chemotest

K-Number: K211666 · 2022-01-09

ApplicantCareglove Global Sdn. Bhd.
Decision Date2022-01-09
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Gloves, Blue Chemotest is a medical device manufactured by Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2022-01-09 under approval number K211666. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powder Free Nitrile Examination Gloves, Blue Chemotest?

Powder Free Nitrile Examination Gloves, Blue Chemotest is a medical device that received FDA 510(k) clearance on 2022-01-09. It is manufactured by Careglove Global Sdn. Bhd.. The 510(k) number is K211666.

When was Powder Free Nitrile Examination Gloves, Blue Chemotest approved by the FDA?

Powder Free Nitrile Examination Gloves, Blue Chemotest received FDA 510(k) clearance on 2022-01-09, under approval number K211666.

What company makes Powder Free Nitrile Examination Gloves, Blue Chemotest?

Powder Free Nitrile Examination Gloves, Blue Chemotest is manufactured by Careglove Global Sdn. Bhd..

What is the FDA product code for Powder Free Nitrile Examination Gloves, Blue Chemotest?

The FDA product code for Powder Free Nitrile Examination Gloves, Blue Chemotest is LZA.

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Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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